EP2029202A1

EP2029202A1 - Safety device for injecting a medicinal product, such as a lyophilized product

Info

Publication number: EP2029202A1
Application number: EP07788884A
Authority: EP
Inventors: Marc Brunel
Original assignee: Individual
Current assignee: Individual
Priority date: 2006-06-16
Filing date: 2007-06-13
Publication date: 2009-03-04
Anticipated expiration: 2027-06-13
Also published as: US20090270803A1; WO2007144507A1; EP2029202B1

Abstract

The invention relates to a safety device for injecting a medicinal product, such as a lyophilized product, comprising a syringe body (9), a protective casing (19) and locking members (22, 23) for maintaining the syringe body (9) and the protective casing (19) in an injection position. According to the invention, this device comprises members (40) which immobilize the locking members (22, 23) and which can be displaced between a natural initial position, called the deactivation position, in which each locking member (22, 23) is immobilized in a locked state, and a position, called the activation position, which allows each locking member (22, 23) to be switched to an unlocked state. Moreover, actuating members (46), positioned on the trajectory of an intermediate shoulder (32) formed on the plunger rod (6) of the injection device, are designed to bring about a displacement of the blocking members from their deactivation position to their activation position during the ascending movement of the plunger rod.

Description

SECURE DEVICE FOR INJECTING A MEDICINAL PRODUCT SUCH AS A LYOPHILIZED PRODUCT

The invention relates to a secure device for injecting a drug product such as a freeze-dried product.

For obvious safety reasons, current disposable injection devices are commonly equipped with a protective device after use of the injection needle.

In the usual way, such injection devices comprise a syringe body comprising a container carrying an injection needle and provided with a piston actuated by a piston rod equipped with a push button, and a protection device comprising:

A protective case adapted so that said protective case and the syringe body are able to slide relative to one another between an injection position in which the injection needle extends to less partially in the extension of the protective case and a position of protection after use in which the injection needle is entirely housed in the protective case,

And at least one locking member capable of having a locked state for holding the syringe body and the protective case in their injection position, and for switching to an unlocked state able to allow, at the end of the race, piston inside the container, the relative sliding of the syringe body and the protective case to their protective position after use.

It should also be noted that this principle applies both to devices equipped with a sealed injection needle on the container, and to injection devices comprising an injection needle that is attached and dismountably secured by any assembly system known per se (Luer cone ...).

The very design of these injection devices (triggering protection at the end of stroke of the piston) however prohibits them to be used in particular for the injection of drugs requiring reconstitution (solvent - freeze-dried product) before injection, and requiring, for this purpose: a first emptying for injecting the solvent contained in the injection device into a bottle containing the freeze-dried product,

an aspiration of the reconstituted product for the filling of the injection device,

- and the actual injection of the drug product.

Indeed, their design would lead to the triggering of the protection after the first emptying prohibiting the two subsequent steps, In order to overcome this deficiency, a solution particularly described in patent applications FR 2861310 and WO 02/072182 consisted in providing the devices. injection of a suitable "inhibitor organ":

• because of its only presence, or in a first position of the latter, to shorten the piston stroke during the first emptying, in order to avoid triggering the protection at the end of the stroke,

• after its withdrawal, or in a second position of the latter, to allow, during the actual injection, a normal stroke of the piston causing the release of the protection end of stroke. Such a solution has the advantage of requiring only the addition of a simple "inhibiting organ" in order to achieve the desired result.

On the other hand, it has been found that such a solution which requires a specific action deviating from the natural gestures used for the injection of reconstituted products, has been badly received by the medical staff, so that the devices designed according to this principle are in fact a very weak commercial success.

The present invention aims to overcome this drawback and its main objective is to provide a secure injection device for the injection of products to be reconstituted according to a methodology strictly identical to that implemented when using non-injection devices. secure. Another object of the invention is to provide a secure injection device resulting in a very small additional cost compared to current insecure injection devices.

For this purpose, the invention provides a device for injecting a drug product such as a freeze-dried product having the specificity of comprising a protection device comprising:

^• a shoulder provided in the intermediate position of the length of the piston rod,

A locking element secured to one of the elements, syringe body or protective case, comprising:

locking members of the locking members, able to be moved between a natural initial position, called deactivation, locking of each locking member in its locked state, and a position, called activation, authorization of a switching of each locking member to its unlocked state,

and actuators connected to the locking members, positioned in the path of the intermediate shoulder of the piston rod, and adapted to undergo a change of state causing a displacement of said locking members from their deactivation position; towards their activation position, during a bias exerted on said actuating members by the intermediate shoulder, during a displacement of the piston rod resulting from a pull on the push button.

In order to fulfill the intended purpose, the invention therefore mainly requires equipping the conventional secure injection devices with a locking element, and securing the latter, for example by snapping on one of the elements, a body of syringe or protective case, of these injection devices. Therefore, the extra cost generated by the solution according to the invention is very low.

In addition, the transition of the locking members between their natural position of deactivation of the locking members and their position of activation of these locking members takes place automatically, without human intervention, during the suction of the reconstituted product to fill the injection device. Consequently, the methodology implemented for the injection of products to be reconstituted is strictly identical to that used when using insecure injection devices.

According to a first advantageous variant embodiment of the invention:

^• the locking element is secured on one of the components, syringe body or protective case, with a faculty of travel in a direction parallel to the longitudinal axis of the protection device, between two positions defining the respective positions of deactivation and activating the locking members of the locking members,

The actuating members comprise at least one lever articulated on the locking element around a pivot axis and comprising, extending on either side of said pivot axis: a contact zone situated on the path of the intermediate shoulder of the piston rod,

- And at least one bracing piece capable of generating a movement of the locking member causing a displacement of the locking members from their deactivated position to their activation position, during a pivoting of the lever caused by the displacement of the piston rod resulting from a pull exerted on the push button.

According to a second advantageous variant embodiment of the invention: the locking element is secured in a fixed position to one of the elements, syringe body or protective case,

The actuating members comprise at least one locking piece integral with the locking element, comprising in one piece - a contact zone located in the path of the intermediate shoulder of the piston rod,

at least one locking member of a locking member, and a deformable zone of connection between the contact zone and each locking member, able to deform and to cause a displacement of each locking member from its deactivating position to its activation position, during a biasing exerted on the contact zone by the intermediate shoulder, during a displacement of the piston rod resulting from a pull exerted on the push button.

Furthermore, according to the invention, the locking element is advantageously secured to the syringe body.

In addition, in order to complete the locking of the locking fingers, the locking members of the locking member and said locking members advantageously comprise complementary removable assembly members of the type notch / lug.

Furthermore, when the locking members, holding the syringe body and the protective case in their injection position, usually consist of flexible blades, the locking members of said locking members are then advantageously adapted, according to the invention, to prohibit, in their deactivation position, the bending deformation of the latter.

Other features, objects and advantages of the invention will emerge from the detailed description which follows with reference to the accompanying drawings which show by way of non-limiting examples two preferred embodiments. On these drawings:

FIG. 1a is a perspective view showing a locking element adapted to equip a first embodiment of an injection device according to the invention shown in perspective in FIG. 1b,

FIG. 2 is a longitudinal view of a piston rod of an injection device according to the invention,

FIGS. 3 and 4 are longitudinal sections respectively through a plane A and an axial plane B of the first embodiment of the injection device according to the invention, shown in perspective in FIGS. 1a and 1b;

FIG. 5a is a perspective view showing a locking element adapted to equip a second mode embodiment of an injection device according to the invention shown in perspective in FIG. 5b,

FIGS. 6 and 7 are longitudinal sections respectively through the axial plane B and the plane A of the second embodiment of the injection device according to the invention, shown in perspective in FIGS. 5a and 5b;

- Figures 8 and 9 are two partial longitudinal sections of the first embodiment of the injection device according to the invention each showing, in half section through the plane A and in half section through the plane B, one of the steps of operation of this injection device,

FIG. 10 is a longitudinal view of the first embodiment of injection device according to the invention representing the latter during the final stage of the end of injection, and FIG. 11 is a partial longitudinal section of the second embodiment of injection device according to the invention showing, in half section through the plane A and half section through the plane B, the step of operation of the injection device corresponding to that shown in Figure 8 with reference to the first injection device. The two variants of injection devices according to the invention shown by way of example in the figures are of the disposable type and consist of injection devices particularly suitable for the injection of drugs requiring reconstitution (solvent - freeze-dried product). before injection, and requiring, for this purpose: a first emptying for injecting the solvent contained in the injection device in a bottle containing the freeze-dried product,

- Aspiration of the reconstituted product for filling the injection device, - and the actual injection of the drug product.

In addition, these two variants of injection devices incorporate protective devices adapted to allow to protect their injection needle after use. In the first place, each of these injection devices comprises a container such as, for example, a conventional syringe 1 consisting of a glass tube, on the one hand, extended by a base 2 in which a needle is sealed. injection 3, and secondly, provided with an outer collar 4 at its end opposite the base 2.

In addition, this syringe 1 is conventionally equipped with a piston 5 adapted to slide tightly inside the latter, and secured, for its actuation, on one end of a piston rod 6 provided with level of its opposite end, a push button 7 having the shape of a cup, that is to say having a face 7a junction with the piston rod 6, convex shape.

As mentioned above, these two injection devices further comprise a protection device after use of the injection needle 3. According to the two examples shown in the figures, these two protection devices consist of devices of the same design. basic that the injection devices marketed by the company "SAFETY SYRINGES, Inc.", and described in particular in the patent applications WO 2006/127484 and WO 2006/050304, and the patents US 6,030,366 and US 6,623,459, these documents being considered, because of their referencing, as an integral part of this description.

Firstly, the device for protecting the first injection device represented in FIGS. 1b, 3 and 4 comprises a syringe body 8 of the type described in patent application WO 2006/050304, comprising a longitudinal duct 9 defining a housing. for the syringe 1, provided at one of its ends with an outer ring 10 for abutment and support of the flange 4 of said syringe.

This syringe body 8 further comprises a tubular digital gripping head 11 formed around the end section of the longitudinal duct 9 on which the crown 10 is formed. This tubular head 11 is formed of two half shells.

12, 13 extending symmetrically on either side of the ring and each connected to the latter by two parallel arms extended, each, with a trigger 16, 17 elastically deformable, and adapted so that the triggers 16, 17 of two coplanar arms define, with the opposite face of the 10, a housing 18 and locking the outer flange 4 of the syringe 1.

The protection device of the first injection device according to the invention also comprises a protective case 19 adapted to slide externally along the tubular conduit 9 of the syringe body 8.

This protective case 19 comprises, firstly, two digital gripping fins 21, 22 arranged and shapes adapted to substantially close the open face facing the tubular head 11. In addition, this protective case 19 comprises two fingers of 22, 23 arranged to extend symmetrically on either side of the tubular duct 9, each from one of the digital gripping fins 20, 21, and adapted to lock in translation the protective case 19 relative to the syringe body 8, in a retracted relative position of said protective case where the injection needle 3 protrudes from the latter.

Each of these locking fingers 22, 23 consists of an elastically deformable blade extending beyond the flange 4 of the syringe 1 locked in the lumens 18, and extending, in particular, for this purpose within a notch 24, shown in FIG. 9, formed on the periphery of the ring 10 of the syringe body 8.

Each blade 22, 23 further comprises an intermediate locking member adapted to rest and lock on the ring 10 on either side of the notch 24 formed in the latter, the said locking member consisting of a cross defining two locking studs 25, 26 extending on either side of said blade.

Each blade 22, 23 comprises, finally, a bead 27 formed at its free end and adapted to form a bearing surface complementary to the convex face of the push button 7 of the piston rod 6, able to trigger an unlocking of the locking studs 25, 26 by deformation of each blade 22, 23 at the end of stroke of said piston rod 6.

The protective case also comprises four locking fingers such as 28, 29 distributed around the tubular duct 9, each arranged to extend from one of the digital intake fins 20, 21, and adapted to lock in translation the protective case 19 relative to the syringe body 8, in a deployed relative position of said protective case where the injection needle 3 is entirely housed in the latter.

Each of these locking fingers 28. 29 consists of an elastically deformable blade provided, at its free end, with a locking pin 30 adapted to be housed in a notch 31 formed along the longitudinal duct 9 , and shown in Figure 10.

Usually, the protective device also comprises a spring (not shown) disposed between the syringe body 8 and the protective case 19 and adapted to cause relative sliding of the latter at the end of injection.

According to the invention and, firstly, the piston rod 6 comprises a flange 32 formed in the intermediate position of the length of said piston rod. According to the invention, in addition, the protection devices comprise a locking element adapted to collaborate with the aforementioned flange 32 in order to automatically present a state capable of:

to prohibit the triggering of the release of the unlocking studs 25, 26, during the first actuation of the piston rod 6 to allow the product to be mixed,

- And to allow the triggering of unlocking of the unlocking studs 25, 26, during the second actuation of the piston rod 6 for the injection of the product.

With regard to the protection device of the first embodiment of the injection device according to the invention, this locking element 33 is adapted to fit inside the digital capture head 11.

It comprises a locking plate 34 adapted to extend substantially in the plane of the face of the digital gripping head opposite to the digital gripping wings 20, 21, with respect to which four feet such as 35, 36 adapted to extend inside the digital pick-up head 11, and ending with a hook 37 delimiting a longitudinal groove 38 adapted to house, with a clearance clearance, the rim of the crown 10. The locking plate 34 further comprises, facing each locking pin 22, 23, a U-shaped cutout 39 defining two parallel branches 40, 41 adapted to be positioned in abutment each against a locking pin 25, 26 In order to complete the locking of the locking fingers 22, 23, the end face of each leg 40, 41 has, in addition, the shape of a lug 42 adapted to be housed in a notch 43 of complementary shape arranged in the opposite face of each locking pin 25, 26. This locking plate 34 further comprises, associated with each locking pin 22, 23, a lever 44 articulated about a pivot axis 45 orthogonal to the longitudinal axis of the syringe body 8, said lever comprising:

extending on one of the sides of the pivot axis 45, a flat abutment piece 46 of the intermediate flange 32 of the piston rod 6, arranged so as to be located on the path of said collar, the said abutment piece having, in addition, a free edge 46a beveled capable of facilitating the passage of the flange 32 during a displacement of the piston 5 in the direction of the emptying of the syringe 1, - and extending from the other side of the pivot axis

45, two parallel branches 47, 48 each adapted to bear, at its free end, on a locking pin 25, 26.

The operation of this first injection device is described below with reference to FIGS. 3, 4, 8, 9 and 10. In the initial position of the injection device represented in FIGS. 3 and 4, the locking element 33 is positioned so that the lugs 42 of the branches 40, 41 are housed in the notches 43 of the locking studs 25, 26.

This locking element 33 is thus in a so-called deactivation position in which it prevents any relative spacing of the locking fingers 22, 23, and therefore any unlocking of said locking fingers.

The first actuation of the piston 5 to empty the syringe for the purpose of mixing the solvent and the freeze-dried product, does not generate no change in the position of the locking element 33: the passage through the intermediate flange 32 of the piston rod 6 of the obstacle constituted by the abutment piece 46 does not cause, in effect, a tilting without consequence However, as shown in FIG. 8, during the suction of the mixture inside the syringe 1, the intermediate flange 32 abuts against the abutment piece 46 and causes the lever 44 to tilt. which causes a bracing of the branches 47, 48 on the locking studs 25, 26: the locking element 33 undergoes an axial displacement and is positioned in a so-called activation state in which the arms 40, 41 are arranged beyond the locking studs 25, 26 and therefore no longer oppose the relative spacing of the locking fingers 22, 23.

As a result, and as shown in FIG. 9, when the piston 5 reaches the end of the stroke, the push-button 7 triggers the unlocking of the unlocking fingers 22, 23, and thus causes the syringe body 8 to slide relative to each other. from the protective case 19 until an extended relative position of the protective case 19, represented in FIG. 10, materialized by the cooperation of the locking lugs 30 and the notches 31, and in which the injection needle 3 is housed inside said protective case.

The protective device of the second embodiment of injection device according to the invention shown in Figures 5b, 6 and 7, comprises a syringe body 8 and a protective case similar to those described above. The only significant differences are relative to the locking members adapted to lock in translation the protective case 19 relative to the syringe body 8 in the extended relative position of said protective case where the injection needle 3 is entirely housed in this case. latest. According to this embodiment, in fact these locking members comprise:

a light 30 'formed in the peripheral wall of the digital capture head 11, and a notch 31 'formed on the longitudinal duct 9 of the syringe body 8 towards the free end of the latter.

Similarly, the piston rod 6 is similar to that described above and shown in Figure 2. The essential difference between these two embodiments relates to the locking element.

According to the second embodiment, the locking element 51 is adapted to cap the digital capture head 11.

It comprises a locking plate 52 adapted to extend substantially in the plane of the face of the digital pick-up head 11 opposite to the digital gripping wings 20, 21, with respect to which extends a skirt 53 adapted to cap the pins. two half shells 12, 13.

In addition, this locking element 51 has lugs 54 arranged protruding from the inner face of the skirt 53 and adapted to snap without play under the arms 14, 15 of the tubular head 11.

This locking element 51 further comprises associated with each locking pin 22, 23, a locking piece 55 disposed inside the skirt 53, said locking piece having a clean elasticity and being connected to the skirt 53 by a connection such that it has a faculty of elastic deformation.

This locking piece 55 comprises:

- A frame 56 defining an opening for the passage of one of the locking fingers 22, 23, said frame further comprising a crossmember 57 abutment of the intermediate flange 32 of the piston rod 6, arranged so as to be located in the path of said flange, said stop crossmember further having a free edge 57a beveled adapted to facilitate the passage of the flange 32, during a displacement of the piston 5 in the direction of the emptying of the syringe 1, two branches 58, 59 each extending under one of the uprights of the frame 56 perpendicular to the crossmember 57, so as to be positioned in abutment each against a locking stud 25, 26 of the locking fingers 22, 23 said branches having an end face forming a lug 60 adapted to be housed in the notch 43 of the locking stud 25, 26 facing each other.

According to this principle, the locking element 51 is fixed without play on the digital pick-up head 11, and is initially positioned, as shown in FIGS. 6 and 7, so that the lugs 60 of the branches 58, 59 are housed in the notches 43 of the locking studs 25, 26.

This locking element 51 is thus in a deactivation position in which it prohibits any relative spacing of the locking fingers 22, 23, and therefore any unlocking of said locking fingers.

As previously, the first actuation of the piston 5 to empty the syringe does not cause any change in the position of the locking element.

By cons, as shown in Figure 11, during the suction of the mixture inside the syringe 1, the intermediate flange 32 abuts against the cross member 57 and causes a deformation of the locking member 55 and in particular the branches 58, 59 which cause positioning of the lugs 60 beyond the locking studs 25, 26, for which the said arms are no longer opposed to a relative spacing of the locking fingers 22, 23.

With the addition of a simple locking element, the invention thus leads to converting a disposable secure injection device into a secure injection device which, without requiring any specific action by the user, first actuation of the piston, then the actual injection accompanied by securing.

Claims

1 / secure device for injecting a drug product such as a freeze-dried product, comprising a syringe body (8) comprising a container (1) carrying an injection needle (3) and provided with a piston (5); ) actuated by a piston rod (6) provided with a push button (7), and a protection device comprising:

^• a protective casing (19) adapted so that the said protective case and the syringe body (8) are able to slide relatively with respect to each other between an injection position in which the needle injection (3) extends at least partially in the extension of the protective case (19), and a position of protection after use in which the injection needle (3) is fully housed in the case of protection (19), • and at least one locking member (22, 23) adapted to have a locked state for holding the syringe body (8) and the protective case (19) in their injection position, and to switch to an unlocked state able to allow, at the end of stroke of the piston (5) inside the container (1), the relative sliding of the syringe body (8) and the protective case (19) towards their position of protection after use, the said injection device being characterized in that the device for protection includes:

A shoulder (32) arranged at an intermediate position along the length of the piston rod (6), a locking element (33; 51) secured to one of the elements, a syringe body (8) or a protective case (19), comprising:

- locking members (40, 41; 58; 59) for the locking members (22, 23) capable of being displaced between a natural initial position, referred to as a deactivation, locking position of each locking member (22, 23) in its locked state, and a position, called activation, allowing a switching of each locking member (22, 23) to its unlocked state, And actuating members (44, 57) connected to the locking members (40, 41; 58; 59), positioned in the path of the intermediate shoulder (32) of the piston rod (6), and adapted to undergo a change of state causing a displacement of said locking members from their deactivation position to their activation position, during a bias exerted on said actuating members by the intermediate shoulder (32), when a displacement of the piston rod (6) resulting from a pull exerted on the push button (7).

2 / injection device according to claim 1 characterized in that:

• the locking element (33) is secured to one of the elements, syringe body (8) or protective case (19), with an ability to move in a direction parallel to the longitudinal axis of the protective device, between two positions defining the respective positions of deactivation and activation of the locking members (40, 41) of the locking members (22, 23),

• the actuating members comprise at least one lever (44) articulated on the locking element (33) about a pivot axis (45) and comprising, extending on either side of said axis of pivoting:

a contact zone (46) located in the path of the intermediate shoulder (32) of the piston rod (6),

And at least one bracing piece (47, 48) capable of generating a displacement of the locking element (33) causing the locking members (40, 41) to move from their deactivating position to their position. activation during a pivoting of the lever (44) caused by the displacement of the piston rod (6) resulting from a pull exerted on the push button (7).

3 / injection device according to claim 1 characterized in that:

The locking element (51) is secured in a fixed position to one of the elements, syringe body (8) or protective case

(19) ^• the actuating members comprise at least one locking piece (55) integral with the locking member (51) having integrally of

a contact zone (57) located in the path of the intermediate shoulder (32) of the piston rod (6),

at least one locking member (58, 59) for a locking member (22, 23),

- and a deformable zone (56) connecting the contact zone (57) and each locking member (58; 59), able to deform and cause a displacement of each locking member (58; 59) of its deactivation position towards its activation position, when the contact zone (57) is urged by the intermediate shoulder (32) during a displacement of the piston rod (6) resulting from a traction exerted on the push button (7). 4 / injection device according to one of the preceding claims characterized in that the locking element (33; 51) is secured to the syringe body (8).

5 / injection device according to one of the preceding claims characterized in that the locking members (40, 41; 58; 59) of the locking member (33; 51) and the locking members (22, 23). ) for holding the syringe body (8) and the protective case (19) in their injection position, comprise complementary detachable assembly members (42, 43, 60, 43), of the cran / ergot type .

6 / injection device according to one of the preceding claims, the locking members (22, 23), holding the syringe body (8) and the protective case (19) in their injection position, consist of flexible blades, characterized in that the locking members (40, 41; 58; 59) of said locking members, are adapted to prohibit, in their deactivation position, the bending deformation of the latter.